title: Five un-easy pieces of pharmaceutical policy reform.
abstract: Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies.
authors.affiliation: Professor at Suffolk University Law School and a Lab Fellow at the Edmond J. Safra Center for Ethics at Harvard University.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Rodwin
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic; D030881:Disclosure; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004502:Education, Medical, Continuing / Q000191:economics; D035082:Federal Government; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D011640:Public Policy; D014481:United States